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    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES

    K Number: K133069 · Decision Oct 24, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    5
    Review Days
    389

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    Basic Information

    Device Name
    CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES
    K Number
    K133069
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Codent Technical Industry Co., Ltd.
    Date Received
    September 30, 2013
    Decision Date
    October 24, 2014
    Product Code
    EFB
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EFB Handpiece, Air-Powered, Dental

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    Other Clearances by Codent Technical Industry Co., Ltd.

    K Number Device Name
    K231864 Fiber Optic Brushless Electronic Micromotor, model: iM100
    K152146 High Speed Handpieces and Accessories
    K150798 Codent Low Speed Dental Handpieces and Accessories
    K033213 CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS